The dCELL Vascular Patch is a sterile, non-cellular biological scaffold manufactured from porcine pericardium which is intended to be permanently implanted into the human body for vascular repair.
Tissue Regenix, joined AIM in June via a reverse takeover of Oxeco, and will manufacture the dCELL Vascular Patch at its York facility.
Tissue Regenix will now be simultaneously working towards receiving FDA approval for the US.
The next product on which Tissue Regenix intends to focus is the dCELL Meniscus, for the repair of damaged knee meniscus.
Tissue Regenix executive chairman John Samuel, said, “The granting of a European CE mark for the dCELL Vascular Patch, our first product approved for launch, is an historic moment for Tissue Regenix. As well as providing access to some of the world’s largest medical devices markets, today’s announcement acts as a validation of our dCELL technology platform.”